Table 2. Adverse Eventsa.
| Events | No. (%) of Patients With Event | |
|---|---|---|
| Recombinant Human Pentraxin 2 (n = 77) | Placebo (n = 39) | |
| Any adverse event | 71 (92) | 36 (92) |
| Most frequent adverse eventsb | ||
| Cough | 14 (18) | 2 (5) |
| Fatigue | 13 (17) | 4 (10) |
| Nasopharyngitis | 12 (16) | 9 (23) |
| Headache | 11 (14) | 3 (8) |
| Idiopathic pulmonary fibrosis | 11 (14) | 5 (13) |
| Diarrhea | 9 (12) | 2 (5) |
| Bronchitis | 8 (10) | 5 (13) |
| Dyspnea | 7 (9) | 4 (10) |
| Upper respiratory tract infection | 7 (9) | 5 (13) |
| Back pain | 3 (4) | 4 (10) |
| Severe adverse eventsc | 7 (9) | 2 (5) |
| Serious adverse eventsd | 6 (8) | 4 (10) |
| Fatal adverse events | 0 | 1 (3) |
| Adverse events leading to discontinuation | 2 (3) | 1 (3) |
| Pneumonia | 0 | 1 (3) |
| Lung carcinoma cell type unspecified stage II | 1 (1) | 0 |
| Idiopathic pulmonary fibrosis | 1 (1) | 0 |
Events occurring after the patient received treatment.
The most frequent adverse events were defined as those with an incidence greater than 10% in any study group ordered by frequency of occurrence in the recombinant human pentraxin 2 group. eTable 2 in Supplement 2 shows adverse events with an incidence greater than 5%.
Adverse events were graded as follows: grade 1 (mild) asymptomatic or mild symptoms and clinical or diagnostic observations only; grade 2 (moderate) minimal, local, or noninvasive intervention indicated; grade 3 (severe) medically significant but not immediately life threatening; grade 4 (life threatening) life threatening consequences with urgent intervention indicated; and grade 5 (fatal), death related to adverse event.
A serious adverse event was defined as any adverse event that resulted in death, was immediately life threatening, resulted in persistent or clinically significant disability or incapacity, required or prolonged hospitalization, was related to a congenital anomaly or birth defect, or was deemed serious for any other reason.