Table 3. Frequency of Side Effects and Adverse Events by Treatment Arm.
| Variable | Standard Therapy (No. %) | Extended Therapy (No. %) |
|---|---|---|
|
|
|
|
| Deaths | 0/286 (0) | 0/282 (0) |
| Withdrawal due to Adverse Event | 0/286 (0) | 1/282 (0.4) |
| Any Self-reported Serious Symptom | 143/286 (50) | 142/282 (50.4) |
| Serious Adverse Event | 1/286 (0.4) | 3/282 (1.1) |
| Week 1 Self-reported Serious Symptoms | ||
| Headache | 5/252 (2.0) | 3/247 (1.2) |
| Nausea | 1/252 (0.4) | 3/247 (1.2) |
| Alertness | 11/252 (4.4) | 16/247 (6.5) |
| Coughing | 5/252 (2.0) | 3/247 (1.2) |
| Pounding Heart | 3/252 (1.2) | 2/247 (0.8) |
| Diarrhea | 2/252 (0.8) | 0/247 (0) |
| Sleep Problems | 7/252 (2.8) | 19/247 (7.7)* |
| Skin Irritation or Rash | 4/252 (1.6) | 3/247 (1.2) |
| Calmness | 5/252 (2.0) | 9/247 (3.6) |
| Dizziness | 1/252 (0.4) | 1/247 (0.4) |
| Light Headedness | 1/252 (0.4) | 2/247 (0.8) |
| Sweating | 8/252 (3.2) | 3/247 (1.2) |
| Good or “High” Feeling | 4/252 (1.6) | 7/247 (2.8) |
| Watery Eyes | 3/252 (1.2) | 3/247 (1.2) |
| Coldness of Hands/Feet | 7/252 (2.8) | 6/247 (2.4) |
| Week 12 Self-reported Serious Symptoms | ||
| Headache | 2/134 (1.5) | 0/182 (0) |
| Nausea | 1/134 (0.7) | 1/182 (0.5) |
| Alertness | 9/134 (6.7) | 17/182 (9.3) |
| Coughing | 3/134 (2.2) | 5 (2.7) |
| Pounding Heart | 2/134 (1.5) | 0/182 (0) |
| Diarrhea | 0/134 (0) | 0/182 (0) |
| Sleep Problems | 6/134 (4.5) | 2/182 (1.1) |
| Skin Irritation or Rash | 1/134 (0.7) | 1/182 (0.5) |
| Calmness | 4/134 (3.0) | 5/182 (2.7) |
| Dizziness | 0/134 (0) | 1/182 (0.5) |
| Light Headedness | 1/134 (0.7) | 1/182 (0.5) |
| Sweating | 2/134 (1.5) | 4/182 (2.2) |
| Good or “High” Feeling | 3/134 (2.2) | 4/182 (2.2) |
| Watery Eyes | 2/134 (1.5) | 1/182 (0.5) |
| Coldness of Hands/Feet | 2/134 (1.5) | 3/182 (1.6) |
Note. Any Self-reported Serious Symptom refers to the total number of participants who reported a severe side effect on the checklist across all time-points where side effects were assessed; a Serious Adverse Event refers to the total number of participants who reported a serious adverse event. Week 1 and week 12 Self-reported Serious Symptoms are those rated as 4 (severe) on the side effects checklist; No. = number of participants; * refers to difference between standard and extended treatment (p = 0.014); all items were scored such that higher values reflected greater severity of the item, even for positive items such as good or high feeling, alertness, and calmness