Trial Outcomes & Findings for Efficacy and Safety of Intravenous Neridronic Acid in CRPS (NCT NCT03530345)
NCT ID: NCT03530345
Last Updated: 2020-08-06
Results Overview
In the Baseline Phase and in Treatment Period A/Follow-up Period 1, participants were asked to assessed their average CRPS-related pain on an 11-point numerical rating scale (NRS) - from 0 = "no pain" to 10 = "pain as bad as you can imagine" and report it once daily (in the evening, 24-hour recall) in an electronic diary. Changes from baseline (average for the Baseline Phase) to the weekly average for Week 12 were calculated.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
From the Baseline Phase (Day -7 to Day -1) to Week 12
Results posted on
2020-08-06
Participant Flow
First participant enrollment on 30 May 2018. After a pooled interim analysis of primary endpoint data of studies KF7013-02 and KF7013-04 (NCT03560986), recruitment was stopped as interim results indicated futility. Last participant's last assessment was on 31 July 2019.
182 participants were enrolled (signed consent), 57 were allocated to treatment and received study medication. Of 125 participants not allocated, 95 did not meet inclusion/met exclusion criteria, 1 was lost to follow-up, 9 withdrew consent, 1 experienced technical problems, and 19 were not allocated for other reasons.
Participant milestones
| Measure |
Neridronic Acid - Treatment Period A/B
* Treatment Period A: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
* Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
|
Placebo - Treatment Period A/B
* Treatment Period A: Matching placebo - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
* Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
|
|---|---|---|
|
Treatment Period A/Follow-up Period 1
STARTED
|
28
|
29
|
|
Treatment Period A/Follow-up Period 1
Treatment Period A Completers
|
26
|
27
|
|
Treatment Period A/Follow-up Period 1
COMPLETED
|
7
|
7
|
|
Treatment Period A/Follow-up Period 1
NOT COMPLETED
|
21
|
22
|
|
Treatment Period B/Follow-up Period 2
STARTED
|
5
|
7
|
|
Treatment Period B/Follow-up Period 2
Treatment Period B Completers
|
4
|
6
|
|
Treatment Period B/Follow-up Period 2
COMPLETED
|
0
|
0
|
|
Treatment Period B/Follow-up Period 2
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Neridronic Acid - Treatment Period A/B
* Treatment Period A: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
* Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
|
Placebo - Treatment Period A/B
* Treatment Period A: Matching placebo - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
* Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
|
|---|---|---|
|
Treatment Period A/Follow-up Period 1
Lost to Follow-up
|
1
|
0
|
|
Treatment Period A/Follow-up Period 1
Withdrawal by Subject
|
3
|
1
|
|
Treatment Period A/Follow-up Period 1
Other reasons for discontinuation
|
17
|
21
|
|
Treatment Period B/Follow-up Period 2
Other reasons for discontinuation
|
5
|
7
|
Baseline Characteristics
Efficacy and Safety of Intravenous Neridronic Acid in CRPS
Baseline characteristics by cohort
| Measure |
Neridronic Acid - Treatment Period A
n=28 Participants
Neridronic acid 400 mg administered by 4 intravenous infusions within 10 Days in Treatment Period A.
|
Placebo - Treatment Period A
n=29 Participants
Matching placebo administered by 4 intravenous infusions within 10 Days in Treatment Period A.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
49.4 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
47.8 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Age, Customized
< 18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
From 18 to <65 years
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Age, Customized
From 65 to <85 years
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Customized
85 years and above
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Complex regional pain syndrome (CRPS) type
CRPS Type I
|
25 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Complex regional pain syndrome (CRPS) type
CRPS Type II
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Time since onset of CRPS symptoms
|
17.72 months
n=99 Participants
|
13.47 months
n=107 Participants
|
14.23 months
n=206 Participants
|
|
Time since diagnosis of CRPS
|
9.15 months
n=99 Participants
|
11.37 months
n=107 Participants
|
10.37 months
n=206 Participants
|
PRIMARY outcome
Timeframe: From the Baseline Phase (Day -7 to Day -1) to Week 12Population: Full Analysis Set; all participants treated in Treatment Period A with all data available at the time of last participant out following premature study termination.
In the Baseline Phase and in Treatment Period A/Follow-up Period 1, participants were asked to assessed their average CRPS-related pain on an 11-point numerical rating scale (NRS) - from 0 = "no pain" to 10 = "pain as bad as you can imagine" and report it once daily (in the evening, 24-hour recall) in an electronic diary. Changes from baseline (average for the Baseline Phase) to the weekly average for Week 12 were calculated.
Outcome measures
| Measure |
Neridronic Acid - Treatment Period A
n=28 Participants
Neridronic acid 100 mg - 4 intravenous infusions within 10 Days
|
Placebo - Treatment Period A
n=29 Participants
Matching placebo - 4 intravenous infusions within 10 Days
|
|---|---|---|
|
Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary)
|
-1.23 units on a scale
Standard Error 0.310
|
-0.16 units on a scale
Standard Error 0.305
|
SECONDARY outcome
Timeframe: From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26)Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.
11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). Changes from baseline to Week 26 were planned to be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.
11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). The number of participants with response at Week 12 was planned to be determined.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26)Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.
11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). The number of participants with response at Week 26 was planned to be determined.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.
Dynamic mechanical allodynia: a tactile stimulus is applied in a single sweeping motion (1 cm to 2 cm length) on the skin on the affected limb. The participants are asked to judge the stimulus intensity by means of an NRS (0 to 10). "0" in this case means "no pain". Each "pricking", "stinging" or "burning" sensation is defined as a painful sensation, which should always be evaluated by giving a value greater than "0". "10" corresponds to the individual maximum pain imaginable. Change from baseline was planned to analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.
Pressure pain threshold: using a pressure algometer (contact area 1 cm2), the threshold for pressure-induced pain is measured on the thenar muscle/abductor hallucis muscle in 3 series of slowly increasing stimulus intensities (at a rate of about 50 kPa/s). The threshold is then determined as the arithmetic mean of the 3 series (in kPa). The ratio of the thresholds of the affected limb versus the unaffected limb was planned to be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.
In participants with the CRPS sign of edema on the CRPS severity score at baseline, circumference of the hand or foot will be measured by the investigator with measurement tape using the figure-of-eight method at both the affected limb and the contralateral unaffected limb. Each measurement will be performed 3 times. The average of the 3 measurements will be used for further analysis. The ratio of the averages of the affected limb versus the unaffected limb was planned to be calculated and used for the determination of the change from baseline.
Outcome measures
Outcome data not reported
Adverse Events
Baseline to Week 26: Placebo TPA
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Baseline to Week 26: Neridronic Acid TPA
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Week 26 to Week 52: Placebo TPA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Week 26 to Week 52: Neridronic Acid TPA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Baseline to Week 26: Placebo TPA
n=29 participants at risk
In Treatment Period A, participants received matching placebo - 4 intravenous infusions within 10 Days; Follow-up Period 1 until 26 weeks.
|
Baseline to Week 26: Neridronic Acid TPA
n=28 participants at risk
In Treatment Period A, participants received neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
|
Week 26 to Week 52: Placebo TPA
n=22 participants at risk
Participants with placebo treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
|
Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB
n=7 participants at risk
Participants who had completed treatment with placebo in Treatment Period A/Follow-up Period 1 received neridronic acid treatment (100 mg - 4 intravenous infusions within 10 days) in Treatment Period B/Follow-up Period 2 until 52 weeks.
|
Week 26 to Week 52: Neridronic Acid TPA
n=23 participants at risk
Participants who had completed treatment with neridronic acid treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
|
Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB
n=5 participants at risk
Participants who had completed treatment with neridronic acid in Treatment Period A/Follow-up Period 1 received re-treatment with neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
Other adverse events
| Measure |
Baseline to Week 26: Placebo TPA
n=29 participants at risk
In Treatment Period A, participants received matching placebo - 4 intravenous infusions within 10 Days; Follow-up Period 1 until 26 weeks.
|
Baseline to Week 26: Neridronic Acid TPA
n=28 participants at risk
In Treatment Period A, participants received neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.
|
Week 26 to Week 52: Placebo TPA
n=22 participants at risk
Participants with placebo treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
|
Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB
n=7 participants at risk
Participants who had completed treatment with placebo in Treatment Period A/Follow-up Period 1 received neridronic acid treatment (100 mg - 4 intravenous infusions within 10 days) in Treatment Period B/Follow-up Period 2 until 52 weeks.
|
Week 26 to Week 52: Neridronic Acid TPA
n=23 participants at risk
Participants who had completed treatment with neridronic acid treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.
|
Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB
n=5 participants at risk
Participants who had completed treatment with neridronic acid in Treatment Period A/Follow-up Period 1 received re-treatment with neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Eye disorders
Dry eye
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Eye disorders
Eye pain
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Burning mouth syndrome
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Dental paraesthesia
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
7.1%
2/28 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Gingival discomfort
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Nausea
|
13.8%
4/29 • Number of events 4 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
7.1%
2/28 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Acute phase reaction
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
14.3%
4/28 • Number of events 7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
42.9%
3/7 • Number of events 6 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Chest pain
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Fatigue
|
6.9%
2/29 • Number of events 5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Feeling cold
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Influenza like illness
|
6.9%
2/29 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Oedema peripheral
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
7.1%
2/28 • Number of events 5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
14.3%
1/7 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
General disorders
Pyrexia
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Infections and infestations
Bronchitis
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
7.1%
2/28 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Investigations
Lipase increased
|
3.4%
1/29 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
14.3%
1/7 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
7.1%
2/28 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Nervous system disorders
Headache
|
10.3%
3/29 • Number of events 6 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
7.1%
2/28 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Nervous system disorders
Migraine
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Surgical and medical procedures
Foot operation
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
3.6%
1/28 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
14.3%
1/7 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
14.3%
1/7 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
14.3%
1/7 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/23 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
|
Surgical and medical procedures
Medical device implantation
|
0.00%
0/29 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/28 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/22 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/7 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
4.3%
1/23 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
0.00%
0/5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below.
Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right to review any proposed full publication or poster or presentation of the results of this study by the coordinating or other investigator before they are submitted for publication or public disclosure. Neither the sponsor nor the coordinating investigator has the right to prohibit publication or public disclosure. Publication or public disclosure can be postponed for patent purposes.
- Publication restrictions are in place
Restriction type: OTHER