TECENTRIQ
SAFETY PROFILE
Summary of adverse reactions occurring in patients treated with TECENTRIQ monotherapy in clinical trials2
Adverse drug reaction |
TECENTRIQ (n=3178) | |||
---|---|---|---|---|
System Organ Class |
All Grades (%) |
Grade 3 - 4 (%) |
Grade 5 (%) |
Frequency (All Grades) |
Blood and Lymphatic System Disorders |
||||
Thrombocytopenian |
116 (3.7%) |
27 (0.8%) |
0 (0%) |
Common |
Cardiac Disorders |
||||
Myocarditisa |
- |
- |
- |
Rare |
Endocrine Disorders |
||||
Hypothyroidismb |
164 (5.2%) |
6 (0.2%) |
0 (0%) |
Common |
Hyperthyroidismc |
30 (0.9%) |
1 (<0.1%) |
0 (0%) |
Uncommon |
Adrenal insufficiencyd |
11 (0.3%) |
2 (<0.1%) |
0 (0%) |
Uncommon |
Hypophysitisy |
2 (<0.1%) |
0 (0%) |
0 (0%) |
Rare |
Diabetes mellituse |
10 (0.3%) |
6 (0.2%) |
0 (0%) |
Uncommon |
Gastrointestinal Disorders |
||||
Diarrhoeao |
626 (19.7%) |
36 (1.1%) |
0 (0%) |
Very Common |
Dysphagia |
82 (2.6%) |
16 (0.5%) |
0 (0%) |
Common |
Colitisf |
34 (1.1%) |
18 (0.6%) |
0 (0%) |
Common |
Nausea |
747 (23.5%) |
35 (1.1%) |
0 (0%) |
Very Common |
Vomiting |
477 (15.0%) |
26 (0.8%) |
0 (0%) |
Very Common |
Abdominal pain |
268 (8.4%) |
34 (1.1%) |
0 (0%) |
Common |
Pancreatitisg |
18 (0.6%) |
13 (0.4%) |
0 (0%) |
Uncommon |
Oropharyngeal painq |
131 (4.1%) |
0 (0%) |
0 (0%) |
Common |
General Disorders and Administration Site Conditions |
||||
Chills |
207 (6.5%) |
2 (<0.1%) |
0 (0%) |
Common |
Fatigue |
1142 (35.9%) |
109 (3.4%) |
0 (0%) |
Very Common |
Asthenia |
461 (14.5%) |
63 (2.0%) |
0 (0%) |
Very Common |
Influenza like illness |
186 (5.9%) |
1 (<0.1%) |
0 (0%) |
Common |
Pyrexia |
638 (20.1%) |
17 (0.5%) |
0 (0%) |
Very Common |
Infusion related reactionh |
34 (1.1%) |
5 (0.2%) |
0 (0%) |
Common |
Hepatobiliary Disorders |
||||
ALT increased |
167 (5.3%) |
46 (1.4%) |
0 (0%) |
Common |
AST increased |
180 (5.7%) |
46 (1.4%) |
0 (0%) |
Common |
Hepatitisi |
62 (2.0%) |
25 (0.8%) |
2 (<0.1%) |
Common |
Immune System Disorders |
||||
Hypersensitivity |
36 (1.1%) |
3 (<0.1%) |
0 (0%) |
Common |
Infections and Infestations |
||||
Urinary tract infectionp |
368 (11.6%) |
86 (2.7%) |
0 (0%) |
Very Common |
Metabolism and Nutrition Disorders |
||||
Decreased appetite |
810 (25.5%) |
35 (1.1%) |
0 (0%) |
Very Common |
Hypokalaemiav |
142 (4.5%) |
33 (1.0%) |
0 (0%) |
Common |
Hyponatremiaw |
171 (5.4%) |
98 (3.1%) |
0 (0%) |
Common |
Hyperglycaemia |
103 (3.2%) |
32 (1.0%) |
0 (0%) |
Common |
Musculoskeletal and Connective Tissue Disorders |
||||
Arthralgia |
441 (13.9%) |
23 (0.7%) |
0 (0%) |
Very Common |
Back pain |
487 (15.3%) |
52 (1.6%) |
0 (0%) |
Very Common |
Musculoskeletal painr |
489 (15.4%) |
36 (1.1%) |
0 (0%) |
Very Common |
Myositist, u |
13 (0.4%) |
5 (0.2%) |
0 |
Uncommon |
Nervous System Disorders |
||||
Headache |
352 (11.1%) |
10 (0.3%) |
0 (0%) |
Very Common |
Guillain-Barré syndromej |
5 (0.2%) |
4 (0.1%) |
0 (0%) |
Uncommon |
Meningoencephalitisk |
14 (0.4%) |
6 (0.2%) |
0 (0%) |
Uncommon |
Myasthenic syndromez |
1 (<0.1%) |
0 (0%) |
0 (0%) |
Rare |
Renal and Urinary Disorders |
||||
Blood creatinine increasedaa |
171 (5.4%) |
14 (0.4%) |
0 (0%) |
Common |
Nephritiss |
3 (<0.1%) |
1 (<0.1%) |
0 (0%) |
Rare |
Respiratory, Thoracic, and Mediastinal Disorders |
||||
Cough |
660 (20.8%) |
9 (0.3%) |
0 (0%) |
Very Common |
Dyspnoea |
651 (20.5%) |
117 (3.7%) |
1 (<0.1%) |
Very Common |
Hypoxiax |
75 (2.4%) |
36 (1.1%) |
0 (0%) |
Common |
Nasal congestion |
101 (3.2%) |
0 (0%) |
0 (0%) |
Common |
Pneumonitisl |
87 (2.7%) |
27 (0.8%) |
1 (<0.1%) |
Common |
Nasopharyngitis |
141 (4.4%) |
0 (0%) |
0 (0%) |
Common |
Skin and Subcutaneous Tissue Disorders |
||||
Rashm |
619 (19.5%) |
34 (1.1%) |
1 (<0.1%) |
Very Common |
Pruritus |
400 (12.6%) |
7 (0.2%) |
0 (0%) |
Very Common |
Dry Skin |
187 (5.9%) |
1 (<0.1%) |
0 (0%) |
Common |
Vascular Disorders |
||||
Hypotension |
102 (3.2%) |
20 (0.6%) |
0 (0%) |
Common |
No filter results
References for above table
a. Reported in studies outside the pooled dataset. The frequency is based on the program-wide exposure.
b. Includes reports of hypothyroidism, blood thyroid stimulating hormone increased, blood thyroid stimulating hormone decreased, thyroiditis, autoimmune hypothyroidism, euthyroid sick syndrome, myxoedema, thyroid function test abnormal, thyroiditis acute, thyroxine decreased
c. Includes reports of hyperthyroidism, Basedow’s disease, endocrine ophthalmopathy, exophthalmos
d. Includes reports of adrenal insufficiency, primary adrenal insufficiency
e. Includes reports of diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis and ketoacidosis
f. Includes reports of colitis, autoimmune colitis, colitis ischaemic, colitis microscopic, colitis ulcerative
g. Includes reports of pancreatitis, autoimmune pancreatitis, pancreatitis acute, lipase increased and amylase increased
h. includes infusion related reaction and cytokine release syndrome
i. Includes reports of ascites, autoimmune hepatitis, hepatocellular injury, hepatitis, hepatitis acute, hepatotoxicity, liver disorder, drug-induced liver injury, hepatic failure, hepatic steatosis, hepatic lesion, oesophageal varices haemorrhage, varices oesophageal
j. Includes reports of Guillain-Barré syndrome and demyelinating polyneuropathy
k. Includes reports of encephalitis, meningitis, photophobia
l. Includes reports of pneumonitis, lung infiltration, bronchiolitis, interstitial lung disease, radiation pneumonitis.
m. Includes reports of rash, rash maculo-papular, erythema, rash pruritic, dermatitis acneiform, eczema, dermatitis, rash erythematous, skin ulcer, rash papular, folliculitis, rash macular, skin exfoliation, erythema multiforme, rash pustular, dermatitis bullous, furuncle, acne, drug eruption, palmar-plantar erythrodysaesthesia syndrome, seborrhoeic dermatitis, dermatitis allergic, rash generalised, erythema of eyelid, skin toxicity, toxic epidermal necrolysis, toxic skin eruption, dermatitis exfoliative generalised, exfoliative rash, eyelid rash, fixed eruption, generalised erythema, rash papulosquamous, rash vesicular
n. Includes reports of thrombocytopenia and platelet count decreased
o. Includes reports of diarrhoea, frequent bowel movements, and gastrointestinal hypermotility
p. Includes reports of urinary tract infection, cystitis, pyelonephritis, Escherichia urinary tract infection, pyelonephritis acute, urinary tract infection bacterial, kidney infection, urinary tract infection fungal, urinary tract infection pseudomonal
q. Includes reports of oropharyngeal pain, throat irritation, oropharyngeal discomfort
r. Includes reports of musculoskeletal pain, myalgia, bone pain
s. Includes reports of nephritis and Henoch-Schonlein Purpura nephritis
t. Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present
u. Fatal cases have been reported in studies outside the pooled dataset
v. Includes reports of hypokalaemia and blood potassium decreased
w. Includes reports of hyponatraemia and blood sodium decreased
x. Includes reports of hypoxia, oxygen saturation decreased, PO2 decreased
y. Includes reports of hypophysitis and temperature regulation disorder
z. Includes report of myasthenia gravis
aa. Includes reports of blood creatinine increased and hypercreatininaemia
Summary of adverse reactions occurring in patients treated with TECENTRIQ combination therapy in clinical trials2
Adverse drug reaction |
TECENTRIQ + Combination Treatments (n = 4371) | |||
---|---|---|---|---|
System Organ Class |
All Grades (%) |
Grade 3-4 (%) |
Grade 5 (%) |
Frequency (All Grades) |
Blood and Lymphatic System Disorders |
||||
Anaemia* |
1608 (36.8%) |
631 (14.4%) |
0 (0%) |
Very Common |
Lymphopenia*k |
145 (3.3%) |
63 (1.4%) |
0 (0%) |
Common |
Neutropenia*,a |
1565 (35.8%) |
1070 (24.5%) |
6 (0.1%) |
Very Common |
Thrombocytopenia*,‡, b |
1211 (27.7%) |
479 (11.0%) |
1 (<0.1%) |
Very Common |
Leukopenia*, i |
571 (13.1%) |
245 (5.6%) |
0 (0%) |
Very Common |
Endocrine Disorders |
||||
Hypothyroidism*,‡,c |
586 (13.4) |
9 (0.2%) |
0 (0%) |
Very Common |
Hyperthyroidism‡ |
193 (4.4%) |
7 (0.2%) |
0 (0%) |
Common |
Adrenal insufficiency‡,d |
40 (0.9%) |
8 (0.2%) |
1 (<0.1%) |
Uncommon |
Hypophysitis‡,e |
13 (0.3%) |
5 (0.1%) |
0 (0%) |
Uncommon |
Gastrointestinal Disorders |
||||
Constipation* |
1123 (25.7%) |
24 (0.5%) |
0 (0%) |
Very Common |
Stomatitis* |
351 (8.0%) |
23 (0.5%) |
0 (0%) |
Common |
General Disorders and Administration Site Conditions |
||||
Oedema Peripheral* |
451 (10.3%) |
11 (0.3%) |
0 (0%) |
Very Common |
Infections and Infestations |
||||
Lung infection*h |
564 (12.9%) |
226 (5.2%) |
26 (0.6%) |
Very Common |
Investigations |
||||
Blood alkaline phosphatase increased |
200 (4.6%) |
26 (0.6%) |
0 (0%) |
Common |
Metabolism and Nutrition Disorders |
||||
Hypomagnesemia*j |
403 (9.2%) |
22 (0.5%) |
0 (0%) |
Common |
Nervous System Disorders |
||||
Dizziness* |
408 (9.3%) |
9 (0.2%) |
0 (0%) |
Common |
Dysgeusia* |
269 (6.2%) |
0 (0.0%) |
0 (0%) |
Common |
Peripheral neuropathy*f |
1007 (23.0%) |
107 (2.4%) |
0 (0%) |
Very Common |
Syncope* |
68 (1.6%) |
36 (0.8%) |
0 (0%) |
Common |
Renal and Urinary Disorders |
||||
Nephritis‡, l |
23 (0.5%) |
15 (0.3%) |
0 (0%) |
Uncommon |
Proteinuria*g |
359 (8.2%) |
61 (1.4%) |
0 (0%) |
Common |
Respiratory, Thoracic and Mediastinal Disorders |
||||
Dysphonia* |
236 (5.4%) |
4 (< 0.1%) |
0 (0%) |
Common |
Skin and Subcutaneous Tissue Disorders |
||||
Alopecian |
1152 (26.4%) |
3 (< 0.1%) |
0 (0%) |
Very Common |
Vascular Disorders |
||||
Hypertension*m |
611 (14.0%) |
258 (5.9%) |
0 (0%) |
Very Common |
No filter results
* ADR occurring at a frequency difference of ≥5% (All grades) or ≥2% (Grades 3-4) compared to the control arm‡ Observed rate in the combination represents a clinically relevant difference in comparison to TECENTRIQ monotherapy
References for above table
a. Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis and, granulocytopenia
b. Includes reports of thrombocytopenia and platelet count decreased
c. Includes reports of hypothyroidism, blood thyroid stimulating hormone increased, blood thyroid stimulating hormone decreased, autoimmune thyroiditis, goitre, thyroiditis, thyroxine free decreased, tri−iodothyronine free decreased, thyroid disorder, thyroxine free increased, thyroxine increased, tri−iodothyronine decreased, tri-iodothyronine free increased, blood thyroid stimulating hormone abnormal, euthyroid sick syndrome, myxoedema coma, thyroid function test abnormal, thyroxine decreased, tri-iodothyronine abnormal, silent thyroiditis and thyroiditis chronic
d. Includes reports of adrenal insufficiency, cortisol decreased, adrenocortical insufficiency acute, secondary adrenocortical insufficiency, adrenocorticotropic hormone stimulation test abnormal, Addison's disease, adrenalitis and adrenocorticotropic hormone deficiency
e. Includes reports of hypophysitis and temperature regulation disorder
f. Includes reports of neuropathy peripheral, peripheral sensory neuropathy, polyneuropathy, herpes zoster, peripheral motor neuropathy, autoimmune neuropathy, neuralgic amyotrophy, peripheral sensorimotor neuropathy, axonal neuropathy, lumbosacral plexopathy, neuropathic arthropathy, toxic neuropathy and peripheral nerve infection
g. Includes reports of proteinuria, protein urine present, haemoglobinuria, and nephrotic syndrome, urine abnormality and albuminuria
h. Includes reports of pneumonia, bronchitis, lung infection, lower respiratory tract infection, tracheobronchitis, infective exacerbation of chronic obstructive airways disease, infectious pleural effusion, paracancerous pneumonia, atypical pneumonia, lung abscess, pleural infection and pyopneumothorax
i. Includes reports of white blood cell count decreased and leukopenia
j. Includes reports of hypomagnesaemia and blood magnesium decreased
k. Includes reports of lymphopenia and lymphocyte count decreased
l. Includes reports of nephritis, tubulointerstitial nephritis, autoimmune nephritis, nephritis allergic, glomerulonephritis, nephrotic syndrome and mesangioproliferative glomerulonephritis
m. Includes reports of hypertension, blood pressure increased, hypertensive crisis, blood pressure systolic increased, diastolic hypertension, blood pressure inadequately controlled and retinopathy hypertensive
n. Includes reports of alopecia, madarosis, alopecia areata, alopecia totalis and hypotrichosis