Table 2 Adverse events during follow up.

From: First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries

Adverse event

Number of cases (%)

Level of severity

Degree of seriousness

Outcome

Relation to the application

Treatment-related pain

4 (50.0)

Moderate

Non-serious

Recovered

Not related

Fever

3 (37.5)

Moderate

Non-serious

Recovered

Might be related

Back pain

2 (25.0)

Moderate

Non-serious

Recovered

Not related

Nausea

2 (25.0)

Moderate

Non-serious

Recovered

Might be related

Insomnia

1 (12.5)

Moderate

Non-serious

Recovered

Not related

Itchiness

1 (12.5)

Moderate

Non-serious

Recovered

Not related

Joint pain

7 (87.5)

Mild

Non-serious

Recovered

Not related

CRP elevation

5 (62.5)

Mild

Non-serious

Recovered

Not related

Joint effusion

3 (37.5)

Mild

Non-serious

Recovered

Not related

Postoperative anemia

2 (25.0)

Mild

Non-serious

Recovered

Might be related

Amylase elevation

2 (25.0)

Mild

Non-serious

Recovered

Not related

CPK elevation

2 (25.0)

Mild

Non-serious

Recovered

Not related

ALP elevation

2 (25.0)

Mild

Non-serious

Recovered

Might be related

Swelling

1 (12.5)

Mild

Non-serious

Recovered

Not related

ALT elevation

1 (12.5)

Mild

Non-serious

Recovered

Not related

AST elevation

1 (12.5)

Mild

Non-serious

Recovered

Not related

Eosinophil elevation

1 (12.5)

Mild

Non-serious

Recovered

Not related

Hypersensitive

1 (12.5)

Mild

Non-serious

Recovered

Not related

Hypertension

1 (12.5)

Mild

Non-serious

Recovered

Not related

  1. CRP: C-reactive protein; ALP: alkaline phosphatase; ALT: alanine transaminase; AST: aspartate transferase.