Table 4. Treatment-Emergent Adverse Events (TEAEs).
| No. (%) | ||
|---|---|---|
| Pamrevlumab (n = 181) | Placebo (n = 175) | |
| Any TEAEsa | 160 (88.4) | 151 (86.3) |
| Leading to treatment discontinuation | 1 (0.6) | 7 (4.0) |
| Leading to treatment interruption | 11 (6.1) | 11 (6.3) |
| Related to study treatment | 20 (11.0) | 25 (14.3) |
| Serious TEAEsb | 51 (28.2) | 60 (34.3) |
| Leading to treatment discontinuation | 1 (0.6) | 4 (2.3) |
| Leading to treatment interruption | 4 (2.2) | 9 (5.1) |
| Related to study treatment | 1 (0.6) | 0 |
| Maximum severity of TEAEs | ||
| Mild | 40 (22.1) | 27 (15.4) |
| Moderate | 69 (38.1) | 69 (39.4) |
| Severe | 32 (17.7) | 33 (18.9) |
| Life-threatening | 3 (1.7) | 7 (4.0) |
| Died | 16 (8.8) | 15 (8.6) |
| Most common TEAEs | ||
| Cough | 37 (20.4) | 25 (14.3) |
| Idiopathic pulmonary fibrosis | 28 (15.5) | 30 (17.1) |
| COVID-19 | 23 (12.7) | 17 (9.7) |
| Dyspnea | 19 (10.5) | 16 (9.1) |
| Bronchitis | 14 (7.7) | 14 (8.0) |
| Headache | 13 (7.2) | 12 (6.9) |
| Pneumonia | 13 (7.2) | 14 (8.0) |
| Fatigue | 12 (6.6) | 10 (5.7) |
| Hypertension | 11 (6.1) | 5 (2.9) |
| Upper respiratory tract infection | 11 (6.1) | 6 (3.4) |
| Diarrhea | 10 (5.5) | 11 (6.3) |
| Dizziness | 10 (5.5) | 7 (4.0) |
| Nasopharyngitis | 10 (5.5) | 6 (3.4) |
| Weight loss | 6 (3.3) | 11 (6.3) |
a
Occurred on or after the first dose of study drug and within 60 days after the last dose.
b
Any adverse event or suspected adverse reaction that resulted in any of the following outcomes: death, a life-threatening adverse event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption in the ability to conduct normal life functions, a congenital anomaly or birth defect, and any event considered medically important but not meeting the above criteria and may have required a medical or surgical intervention.