Table 3 -.
ClarIDHy: Safety summary
| Ivosidenib (n= 124) | Placebo (n= 59) | |||
|---|---|---|---|---|
| Adverse reaction | All Grades; n (%) | Grade ≥ 3; n (%) | All Grades; n (%) | Grade ≥ 3; n (%) |
| General disorders and administration site conditions | ||||
| Fatigue/asthenia | 53 (43) | 4 (3) | 18 (31) | 3 (5) |
| Gastrointestinal disorders | ||||
| Nausea | 51 (41) | 3 (2) | 17 (29) | 1 (2) |
| Diarrhea | 43 (35) | 0 | 10 (17) | 0 |
| Abdominal pain1 | 43 (35) | 3 (2) | 13 (22) | 2 (3) |
| Ascites | 28 (23) | 11 (9) | 9 (15) | 4 (7) |
| Vomiting2 | 28 (23) | 3 (2) | 12 (20) | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough3 | 33 (27) | 0 | 5 (9) | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 30 (24) | 2 (2) | 11 (19) | 0 |
| Blood and lymphatic system disorders | ||||
| Anemia | 22 (18) | 8 (7) | 3 (5) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash4 | 19 (15) | 1 (1) | 4 (7) | 0 |
| Nervous system disorders | ||||
| Headache | 16 (13) | 0 | 4 (7) | 0 |
| Peripheral neuropathy5 | 13 (11) | 0 | 0 | 0 |
| Investigations | ||||
| ECG QT prolonged | 12 (10) | 2 (2) | 2 (3) | 0 |
ECG: electrocardiogram
1
Grouped term includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, epigastric discomfort, abdominal tenderness, and gastrointestinal pain.
2
Grouped term includes vomiting and retching.
3
Grouped term includes cough and productive cough.
4
Grouped term includes rash, rash maculo-papular, erythema, rash macular, dermatitis exfoliative generalized, drug eruption, and drug hypersensitivity.
5
Grouped term includes neuropathy peripheral, peripheral sensory neuropathy, and paresthesia.
Data from TIBSOVO Prescribing Information (15)