Trial Outcomes & Findings for Repeat Radiation, Minocycline and Bevacizumab in Patients With Recurrent Glioma (NCT NCT01580969)
NCT ID: NCT01580969
Last Updated: 2019-08-16
Results Overview
Adverse Events were assessed from start of minocycline treatment (one day prior to start of radiation therapy) until 28 days following the end of radiation therapy. Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4.0. Each event was assigned a grade (1-5), with lower grades indicating milder events. Events were categorized as severe (grade 3-4) or non-severe (grade 1-2). All adverse events were recorded, regardless of attribution to study treatment. Reported below are the number of patients who experienced any non-severe AE and the number of patients who experienced any severe AE. A full listing of AEs (severe and non-severe) are listed in the Adverse Events module of the Results section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
From first dose of study treatment to 28 days following radiation therapy (7-8 weeks)
Results posted on
2019-08-16
Participant Flow
Participant milestones
| Measure |
Dose Level 0: 100 mg Bid
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 0: 100 mg Bid
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
Baseline Characteristics
Repeat Radiation, Minocycline and Bevacizumab in Patients With Recurrent Glioma
Baseline characteristics by cohort
| Measure |
Dose Level 0: 100 mg Bid
n=6 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=13 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Age, Continuous
|
59 years
n=99 Participants
|
55 years
n=107 Participants
|
53 years
n=206 Participants
|
55.5 years
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment to 28 days following radiation therapy (7-8 weeks)Population: In dose level 0, three patients were withdrawn prior to completing the reporting period for the primary objective, making them unevaluable, and they were replaced.
Adverse Events were assessed from start of minocycline treatment (one day prior to start of radiation therapy) until 28 days following the end of radiation therapy. Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4.0. Each event was assigned a grade (1-5), with lower grades indicating milder events. Events were categorized as severe (grade 3-4) or non-severe (grade 1-2). All adverse events were recorded, regardless of attribution to study treatment. Reported below are the number of patients who experienced any non-severe AE and the number of patients who experienced any severe AE. A full listing of AEs (severe and non-severe) are listed in the Adverse Events module of the Results section.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=3 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=13 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Any Severe (G3-4) Adverse Event
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Any Non-Severe (G1-2) Adverse Event
|
3 Participants
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until 12 weeks after radiation therapy (15-16 weeks)Population: Patients who did not complete the Dose Limiting Toxicity (DLT) evaluation period (3 patients in Dose Level 0) were excluded from PFS analysis.
Proportion of patients who have not progressed 12 weeks after the end of radiation therapy. Radiographic Assessment in Neurooncology (RANO) criteria will be used to assess progression and response. Estimates were done by Kaplan-Meier methods to account for patients whose data was censored prior to progression.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=3 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=13 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Progression Free Survival (PFS) at 3 Months
|
1.000 probability of survival
Interval 1.0 to 1.0
|
0.667 probability of survival
Interval 0.2995 to 1.0
|
0.646 probability of survival
Interval 0.418 to 0.998
|
SECONDARY outcome
Timeframe: From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)Population: Patients who did not complete the DLT period (3 patients in Dose Level 0) were excluded from PFS analysis.
Proportion of patients who have not progressed 26 weeks after the end of radiation therapy. Radiographic Assessment in Neurooncology (RANO) criteria will be used to assess progression and response. Estimates were done by Kaplan-Meier methods to account for patients whose data was censored prior to progression.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=3 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=13 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Progression Free Survival (PFS) at 6 Months
|
0.667 probability of survival
Interval 0.2995 to 1.0
|
0.333 probability of survival
Interval 0.0673 to 1.0
|
0.277 probability of survival
Interval 0.106 to 0.723
|
SECONDARY outcome
Timeframe: From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)Population: In Dose Level 0, three patients did not complete any follow-up scans and were excluded from analysis. In Dose Level 2, six patients did not complete any follow-up scans and were excluded from analysis.
Tabulation of the best tumor response participants achieved from baseline through 26 weeks after the end of radiation therapy. Radiographic Assessment in Neurooncology (RANO) criteria will be used to assess progression and response.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=3 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=7 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Tabulation of Tumor Best Responses
Not Evaluable per RANO Criteria
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Tabulation of Tumor Best Responses
Complete Response
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tabulation of Tumor Best Responses
Partial Response
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Tabulation of Tumor Best Responses
Stable Disease
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Tabulation of Tumor Best Responses
Progressive Disease
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)Population: 22 patient completed the baseline questionnaire, and 4 patients completed the 26 week post-radiation questionnaire.
The M. D. Anderson Symptom Inventory - Brain Tumors (MDASI-BT) scale was used to assess patients at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Means and standard deviations from baseline and 26 post-radiation are reported here. MDASI-BT is a 28 item assessment using a 0-10 scale. Part 1 contains 22 items and assesses severity of symptoms, with a score range from 0 to 220. Part 2 contains 6 items and assesses the degree to which symptoms interfere with daily life, with a score range from 0 to 60. The Total score adds Part 1 and Part 2 together to assess total symptom burden, with a score range from 0 to 280. For all parts of the assessment, higher scores indicate a lower quality of life and worse symptom burden.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=6 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=13 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Quality of Life Change Over Time
26 Week Post Radiation - Part 1 Score
|
48 units on a scale
Standard Deviation 0
|
55 units on a scale
Standard Deviation NA
Standard deviation not calculated for single participant
|
14 units on a scale
Standard Deviation NA
Standard deviation not calculated for single participant
|
|
Quality of Life Change Over Time
Baseline - Part 1 Score
|
45.83 units on a scale
Standard Deviation 33.43
|
29.67 units on a scale
Standard Deviation 18.77
|
39.08 units on a scale
Standard Deviation 24.23
|
|
Quality of Life Change Over Time
Baseline - Part 2 Score
|
15.67 units on a scale
Standard Deviation 12.61
|
11.67 units on a scale
Standard Deviation 7.51
|
16.85 units on a scale
Standard Deviation 15.38
|
|
Quality of Life Change Over Time
Baseline - Total Score
|
61.5 units on a scale
Standard Deviation 43.91
|
41.33 units on a scale
Standard Deviation 24.09
|
55.92 units on a scale
Standard Deviation 37.78
|
|
Quality of Life Change Over Time
26 Week Post Radiation - Part 2 Score
|
22 units on a scale
Standard Deviation 12.73
|
29 units on a scale
Standard Deviation NA
Standard deviation not calculated for single participant
|
15 units on a scale
Standard Deviation NA
Standard deviation not calculated for single participant
|
|
Quality of Life Change Over Time
26 Week Post Radiation - Total Score
|
70 units on a scale
Standard Deviation 12.73
|
84 units on a scale
Standard Deviation NA
Standard deviation not calculated for single participant
|
29 units on a scale
Standard Deviation NA
Standard deviation not calculated for single participant
|
SECONDARY outcome
Timeframe: From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)Population: 14 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.
The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. Detection Test (DET) measures sensory registration, vigilance, and reaction time. DET is scored based on the speed of performance: mean of the log10 transformed reaction time for correct responses \[measured in log10 milliseconds (MS)\]. Lower scores meant a better performance.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=5 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=6 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Cognitive Change Over Time - DET
Baseline
|
2.72 log10 ms
Standard Deviation 0.2
|
2.51 log10 ms
Standard Deviation .1
|
2.62 log10 ms
Standard Deviation 0.11
|
|
Cognitive Change Over Time - DET
26 Weeks Post Radiation
|
2.79 log10 ms
Standard Deviation NA
Standard deviation not calculated for single participant
|
2.9 log10 ms
Standard Deviation NA
Standard deviation not calculated for single participant
|
2.67 log10 ms
Standard Deviation NA
Standard deviation not calculated for single participant
|
SECONDARY outcome
Timeframe: From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)Population: 16 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.
The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. Identification Test (IDN) measures basic information processing and decision speed. IDN is scored based on the speed of performance: mean of the log10 transformed reaction time for correct responses \[measured in log10 milliseconds (MS)\]. Lower scores meant a better performance.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=5 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=8 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Cognitive Change Over Time - IDN
Baseline
|
2.86 log10 MS
Standard Deviation 0.08
|
2.72 log10 MS
Standard Deviation 0.05
|
2.78 log10 MS
Standard Deviation 0.07
|
|
Cognitive Change Over Time - IDN
26 Weeks Post Radiation
|
2.89 log10 MS
Standard Deviation NA
Standard deviation not calculated for single participant
|
2.97 log10 MS
Standard Deviation NA
Standard deviation not calculated for single participant
|
2.78 log10 MS
Standard Deviation NA
Standard deviation not calculated for single participant
|
SECONDARY outcome
Timeframe: From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)Population: 16 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.
The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. One Card Learning Test (OCLT) measures visuoperceptual learning and memory. OCLT is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCLT questions. The transformed score ranges from 0 to 1.5708 where a higher score means better performance.
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=5 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=8 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Cognitive Change Over Time - OCLT
Baseline
|
0.95 Arcsine [(sqrt) proportion correct]
Standard Deviation 0.18
|
0.91 Arcsine [(sqrt) proportion correct]
Standard Deviation 0.23
|
0.85 Arcsine [(sqrt) proportion correct]
Standard Deviation 0.15
|
|
Cognitive Change Over Time - OCLT
26 Weeks Post Radiation
|
0.94 Arcsine [(sqrt) proportion correct]
Standard Deviation NA
Standard deviation not calculated for single participant
|
0.71 Arcsine [(sqrt) proportion correct]
Standard Deviation NA
Standard deviation not calculated for single participant
|
0.96 Arcsine [(sqrt) proportion correct]
Standard Deviation NA
Standard deviation not calculated for single participant
|
SECONDARY outcome
Timeframe: From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)Population: 16 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.
The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. Groton Maze Learning Test (GMLT) measures special learning and executive functioning, including working memory, error monitoring, and ability to integrate feedback to modify problem solving. GMLT score is the number of errors made (lower score indicates better performance).
Outcome measures
| Measure |
Dose Level 0: 100 mg Bid
n=5 Participants
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 Participants
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=8 Participants
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Cognitive Change Over Time - GMLT
26 Weeks Post Radiation
|
61 errors
Standard Deviation NA
Standard deviation not calculated for single participant
|
87 errors
Standard Deviation NA
Standard deviation not calculated for single participant
|
48 errors
Standard Deviation NA
Standard deviation not calculated for single participant
|
|
Cognitive Change Over Time - GMLT
Baseline
|
96.4 errors
Standard Deviation 31.17
|
90.67 errors
Standard Deviation 38.55
|
84.38 errors
Standard Deviation 31.46
|
Adverse Events
Dose Level 0: 100 mg Bid
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Level 1: 200 mg Bid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2: 400 mg Bid
Serious events: 8 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Level 0: 100 mg Bid
n=6 participants at risk
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 participants at risk
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=13 participants at risk
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Death NOS
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Intracranial hemorrhage
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
23.1%
3/13 • Number of events 5 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
Other adverse events
| Measure |
Dose Level 0: 100 mg Bid
n=6 participants at risk
Patients receiving minocycline 100 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 1: 200 mg Bid
n=3 participants at risk
Patients receiving minocycline 200 mg bid, bevacizumab, and radiation therapy.
|
Dose Level 2: 400 mg Bid
n=13 participants at risk
Patients receiving minocycline 400 mg bid, bevacizumab, and radiation therapy.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • Number of events 2 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • Number of events 4 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
38.5%
5/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • Number of events 4 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Ataxia
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
66.7%
2/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Chills
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Concentration impairment
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
23.1%
3/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
30.8%
4/13 • Number of events 5 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • Number of events 2 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
38.5%
5/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • Number of events 2 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
38.5%
5/13 • Number of events 6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
61.5%
8/13 • Number of events 13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • Number of events 4 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
30.8%
4/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Eye disorders
Eye disorders - Other
|
33.3%
2/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Facial pain
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
23.1%
3/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 5 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
38.5%
5/13 • Number of events 8 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Gait disturbance
|
33.3%
2/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
66.7%
2/3 • Number of events 5 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Hemoglobin increased
|
16.7%
1/6 • Number of events 2 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
66.7%
2/3 • Number of events 7 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • Number of events 6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Irritability
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Localized edema
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
30.8%
4/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
66.7%
2/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
53.8%
7/13 • Number of events 12 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • Number of events 2 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
23.1%
3/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • Number of events 2 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Stomach pain
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
23.1%
3/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
7.7%
1/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
66.7%
2/3 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
38.5%
5/13 • Number of events 9 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Weight gain
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Weight loss
|
16.7%
1/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
15.4%
2/13 • Number of events 3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
33.3%
1/3 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
0.00%
0/13 • AEs were collected starting with the first dose of minocycline treatment until the last dose of study treatment. Serious Adverse Events (SAEs) continued to be collected until 30 days after last dose of study treatment.
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place